drugset / Trial / NCT00174941
Long-Term Safety of Febuxostat in Subjects With Gout.
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable levels in subjects with gout.
Timeline
- Start
- 2001-03
- Primary completion
- 2006-12
- Completion
- 2006-12
Publications
- Results Colwell HH, Hunt BJ, Pasta DJ, Palo WA, Mathias SD, Joseph-Ridge N. Gout Assessment Questionnaire: Initial results of reliability, validity and responsiveness. Int J Clin Pract. 2006 Oct;60(10):1210-7. doi: 10.1111/j.1742-1241.2006.01104.x. Epub 2006 Aug 15.
- Results Schumacher HR Jr, Becker MA, Lloyd E, MacDonald PA, Lademacher C. Febuxostat in the treatment of gout: 5-yr findings of the FOCUS efficacy and safety study. Rheumatology (Oxford). 2009 Feb;48(2):188-94. doi: 10.1093/rheumatology/ken457.
- Results Whelton A, Macdonald PA, Zhao L, Hunt B, Gunawardhana L. Renal function in gout: long-term treatment effects of febuxostat. J Clin Rheumatol. 2011 Jan;17(1):7-13. doi: 10.1097/RHU.0b013e318204aab4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Febuxostat | Small molecule | 40 mg | Oral |
| Subject | Febuxostat | Small molecule | 80 mg | Oral |
| Subject | Febuxostat | Small molecule | 120 mg | Oral |